BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7664113 · Received July 5, 2018

    Report

    Report Number
    3007566237-2018-01992
    Event Type
    Death
    Date Received
    July 5, 2018
    Date of Event
    May 26, 2018
    Report Date
    July 5, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHIRCOP, C., DINGLI, N., AQUILINA, A., ZRINZO, L., AQUILINA, J. MRI-VERIFIED "ASLEEP" DEEP BRAIN STIMULATION IN MALTA THROUGH CROSS BORDER COLLABORATION: CLINICAL OUTCOME OF THE FIRST FIVE YEARS. BRITISH JOURNAL OF NEUROSURGERY. 2018. DOI: 10.1080/026888697.2018.1478061. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) REQUIRES A SPECIALIST MULTIDISCIPLINARY APPROACH AND LIFELONG FOLLOW-UP. PATIENT ACCESS CAN BE A CHALLENGE FOR SMALL NATION STATES. MALTA IS AN ISLAND NATION WITH A POPULATION OF JUST UNDER 450 000. THE NUMBER OF PATIENTS LIKELY TO BENEFIT FROM DBS IS AROUND 5 TO 10 PER YEAR. THIS STUDY EXPLORES THE OUTCOME OF A CROSS BORDER COLLABORATION BETWEEN SPECIALIST SERVICES AT QUEEN SQUARE, LONDON AND A TERTIARY CENTRE IN MALTA. BETWEEN 2011 AND 2015, 35 PATIENTS UNDERWENT MRI-GUIDED AND MRI-VERIFIED DBS WITH 29 RECEIVING BILATERAL SUBTHALAMIC NUCLEUS (STN) DBS FOR PARKINSON¿S DISEASE UNDER GENERAL ANAESTHESIA. PRE-OPERATIVE MOTOR FUNCTION WAS COMPARED WITH ONE YEAR POST-OPERATIVE MOTOR FUNCTION ASSESSMENTS IN 26 PATIENTS (16 MALE; AGE 60 ± 9, RANGE 32¿70; DISEASE DURATION 8.8 ± 2.7). PRE-OPERATIVE AND POSTOPERATIVE QUALITY OF LIFE SCORES WERE ALSO COMPLETED IN 24 PATIENTS. THERE WAS SIGNIFICANT IMPROVEMENT IN OFF-MEDICATION UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) III MOTOR FUNCTION (41.7%), REDUCTION IN LEVODOPA EQUIVALENT DOSE (LED) (30.6%) AND IMPROVEMENT IN QUALITY OF LIFE AS MEASURED BY THE PARKINSON¿S DISEASE QUESTIONNAIRE (PDQ-39) (52.3%) (P < .001). ALL PDQ-39 DIMENSIONS SHOWED SIGNIFICANT IMPROVEMENT EXCEPT COMMUNICATION, WITH GREATEST BENEFIT IN ACTIVITIES OF DAILY LIVING (ADLS) (72.4%) AND STIGMA (66.3%). SURGICAL COMPLICATIONS DID NOT LEAD TO ANY PERMANENT DEFICIT. PATIENTS RECEIVING DBS TO OTHER TARGETS AND FOR DIFFERENT INDICATIONS ALSO BENEFITTED FROM SURGERY. AN MRI-GUIDED AND MRI-VERIFIED APPROACH TO DBS WAS SUCCESSFULLY IMPLEMENTED THROUGH CROSS BORDER COLLABORATION WITH ACHIEVEMENT OF EXPECTED CLINICAL RESULTS. THIS HEALTHCARE COLLABORATION DEVELOPED OUT OF NECESSITY AND OPPORTUNITY, TAKING ADVANTAGE OF A UK-BASED NEUROSURGEON FROM MALTA. THE UK HEALTHCARE SYSTEM BENEFITS FROM NUMEROUS IMMIGRANTS AT CONSULTANT LEVEL. SUCH A MUTUALLY BENEFICIAL ARRANGEMENT COULD ENABLE SUCH INDIVIDUALS TO OFFER THEIR EXPERTISE TO CITIZENS IN THE UK AS WELL AS THEIR COUNTRY OF ORIGIN. REPORTED EVENTS: ONE (B)(6)-YEAR OLD FEMALE PATIENT IMPLANTED WITH BILATERAL INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) DEVELOPED SEVERE VISUAL HALLUCINATIONS WHICH DID NOT RESOLVE DESPITE WITHDRAWAL OF DOPAMINE AGONISTS. THE PATIENT EXPERIENCED RAPID COGNITIVE DECLINE AND PSYCHOSIS IN HER LAST MONTHS UNTIL PASSING AWAY A YEAR AFTER IMPLANT SURGERY. THE PATIENT HAD A 20 YEAR HISTORY OF MOTOR SYMPTOMS OF PD WITH SEVERELY DISABLING DYSKINESIAS, AND HAD GOOD THERAPEUTIC RESULTS PRIOR TO COGNITIVE DECLINE. THE FOLLOWING DEVICE SPECIFICS WERE NOTED: ACTIVA SC (37602/37603), ACTIVA PC (37601), 3389 LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507328 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| O